BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2040681 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00429
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

    Additional Manufacturer Narrative · 1

    ANALYSIS IS CURRENTLY ONGOING. ONCE ANALYSIS IS COMPLETE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED THIS IMPLANTABLE DEVICE AT THE POST-MARKET QUALITY ASSURANCE LABORATORY. A REVIEW OF MEMORY REVEALED THIS DEVICE DECLARED THE BATTERY STATUS ELECTIVE REPLACEMENT INDICATORS (ERI) WHILE IMPLANTED. THIS DEVICE FAILED LABELED LONGEVITY. THIS DEVICE IS PART OF THE SHORTENED REPLACEMENT WINDOW POPULATION. THIS DEVICE HAS BEEN FORWARDED FOR DETAILED ANALYSIS. NO ADVERSE PATIENT EFFECTS REPORTED WITH THE RETURN OF THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T167

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR T167| E110| 4086| 0184| 4518